This substudy is a prospective, observational, open-label, randomised study within the MARCH study. The purpose of this substudy is to investigate the changes in cerebral function parameters at 5 timepoints over 96 weeks of the three different treatment arms within the MARCH study. The investigators hypothesise that there will be improvements in cerebral function in those patients randomised, as part of the parent study, into the maraviroc arms.

the assessments in this CNS substudy will include:

Neurocognitive function as assessed by a computerised testing battery called CogState;

In those randomised to the maraviroc arms (arms 2 and 3) there is an optional Lumbar puncture at week 48. The cerebrospinal fluid will be used to measure maraviroc levels and an ultrasensitive CSF HIV-1 viral load. These results will be matched with levels in the plasma.

participants in the MARCH main study who are eligible for the CNS substudy and provide written informed consent for participation

Criteria

Inclusion Criteria:

Provision of written, informed consent for participation in the substudy

Enrolled into the substudy either at or before the week 0 visit of the main study

Exclusion Criteria:

Pre-existing CNS diseases

Recent head injury (past three months)

Current history of major depression or psychosis

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637233